Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies

PHASE1TerminatedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

August 17, 2018

Primary Completion Date

July 25, 2019

Study Completion Date

July 25, 2019

Conditions
Multiple MyelomaAcute Myeloid LeukemiaNon-Hodgkins LymphomaMyelodysplastic SyndromeAMLMDSNHL
Interventions
DRUG

AMG 397

AMG 397 will be administered orally once or twice weekly as part of a 28-day treatment cycle.

DRUG

Dexamethasone

Dexamethasone will be administered intravenously (IV) or orally on Days 1, 8, 15, and 22 of each 28-day cycle.

DRUG

Azacitidine

Azacitidine will be administered intravenously (IV) or subcutaneously (SC) daily for the first 7 days of a 28-day cycle.

Trial Locations (21)

2050

Royal Prince Alfred Hospital, Camperdown

3004

The Alfred Hospital, Melbourne

4102

Princess Alexandra Hospital, Woolloongabba

10065

Memorial Sloan Kettering Cancer Center, New York

11528

Alexandra Hospital, Athens

13272

Institut Paoli Calmettes, Marseille

14263

Roswell Park Cancer Institute, Buffalo

21201

University of Maryland Greenebaum Cancer Center, Baltimore

24127

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo

32224

Mayo Clinic Florida, Jacksonville

35249

University of Alabama at Birmingham, Birmingham

40138

Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi, Bologna

53226

Froedtert and Med College Wisconsin, Milwaukee

55905

Mayo Clinic Rochester, Rochester

63110

Washington University, St Louis

66205

University of Kansas Cancer Center, Westwood

77030

University of Texas MD Anderson Cancer Center, Houston

85054

Mayo Clinic Arizona, Phoenix

94805

Institut Gustave Roussy, Villejuif

02215

Dana Farber Cancer Institute, Boston

503-8502

Ogaki Municipal Hospital, Ogaki-shi

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY